The primary and paramount skill required for the care of a patient or victim is the establishment and protection of an appropriate airway, an unobstructed pathway to permit passage of gaseous fluid such as air or oxygen into the lungs. Many techniques and devices have been developed to assist in this process. In the hands of the skilled, an endotracheal tube provides the most reliable passage way to the lungs, permitting both enhanced oxygen delivery (respiration) as well as a means to assist the patient with movement of air (ventilation). Many other devices have been developed to secure the airway, the differences among them primarily relating to ease of insertion and level of required skill. Such known devices are typically used by emergency medical field personnel. Once in place, the prior art devices serve a second critical function by preventing entry into the lungs of other materials such as stomach contents, blood, debris, and the like. With the tube in place, the patient's lungs are protected. However, there is little to protect the health care personnel from contamination from the same substances which may include dangerous and infectious material such as viruses and the like.
Common to most known devices is the process of insertion of an object into the pharyngeal cavity through the nose or mouth. Another method is entry through an incision in the neck created by a cricothyroidotomy. The resultant path is directly into the trachea. Predictably, the area of insertion is irritated and frequently there is a corresponding gag or cough reflex by the patient. This is particularly true where entry is made through the nose or mouth. The tube being inserted then functions as a conduit to direct any expelled secretions, such as nebulized partials, liquids and solids, into the environment, exposing the personnel involved. Expelled material has been shown to travel radially as far as sixteen feet, exposing all within that region to the same. The process of intubation and securing the airway requires close proximity of the operator's face and that of the patient. If exposed, contamination of the operators mucous membranes (eyes, mouth, and the like) may occur. The material expelled may contain hazardous and even lethal material such as infectious contaminants like hepatitis virus, bacteria, and the AIDS virus, as well as toxic materials such as cyanide, radioactive substances and the like.
There is a need for an apparatus to be placed over the exposed and open end of a tube during insertion, thus reducing the operator's risk of exposure to potentially contaminating material. It must not, however, interfere with the intubation process Through U.S. Pat. Nos. 3,905,361; 4,090,518; and 4,231,365, it is known that a face shield may be attached to an airway passage. However, the face shield of each of these prior art references is designed to provide a sealed airway and does not function to prevent secretion exposure to health personnel. In each of these devices, an opening exists in the face mask, available for passage of expelled material.
There is a need in the art for a device which may be temporarily attached to an appropriate implement being used to secure the airway, such device serving to deflect and collect expelled secretions during the insertion phase. Once the tube is secured by established procedures, the device should be capable of being easily removed, safely discarded, and replaced with whatever apparatus is needed, such as a ventilator connection or an ambu bag.
When an endotracheal tube is inserted into the patient, the health care provider often uses a malleable stylet in the bore of the tube. With the stylet in place, the otherwise soft flexible tube can be temporarily molded so as to assist the placement of the tube into the trachea. It is most desirable that a device to deflect and collect expelled secretions should be so designed as to permit use of the stylet.
Additionally, there is a temporary but critical period of time during the intubation process during which no supplemental oxygen can be provided. Accordingly, it is most designable that any device employed for deflecting and collecting expelled secretions include a port for attachment to a source of supplemental oxygen. Of course, this modification would only be of use for the patient who is still breathing during the intubation process.